Overview

This trial is active, not recruiting.

Conditions peripheral arterial occlusive disease, atherosclerosis
Treatments remote endarterectomy of the superficial femoral artery, suprageniculate femoropopliteal bypass
Sponsor St. Antonius Hospital
Collaborator UMC Utrecht
Start date October 2004
End date March 2012
Trial size 126 participants
Trial identifier NCT00566436, C-04.04, P.04.1298L

Summary

The objective of this study is to compare remote superficial femoral artery endarterectomy with suprageniculate bypass surgery in the treatment of long occlusions of the superficial femoral artery. The study hypothesis is that patency rates are comparable and therefore the minimal invasive remote superficial femoral artery endarterectomy can be considered in patients presenting with a long occlusion of the superficial femoral artery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients presenting with a long occlusion of the superficial femoral artery enrolled in REA arm will undergo remote endarterectomy of the occluded superficial femoral artery
remote endarterectomy of the superficial femoral artery Remote superficial artery endarterectomy
Exposure of the common femoral, superficial femoral and profunda femoral artery through a single groin incision. Arteriotomy in the proximal SFA followed by dissection of the intima core beyond the occluded segment using the Vollmar ringstripper. The ringstripper is exchanged for a Mollring cutter all under fluoroscopic guidance. With the Mollring Cutter transection of intima core is carried out, remote from the site of entry. After removal of the intima core the transection zone is secured with an aSpire stent after balloon angioplasty. A completion arteriography will verify a patent artery, and embolectomy can be performed when necessary. As indicated a common femoral artery and profundaplasty can be performed and the arteriotomy may be closed with or without patch.
(Active Comparator)
Patients presenting with a long occlusion of the superficial femoral artery enrolled in Bypass arm will undergo suprageniculate femoropopliteal bypass surgery to bypass the occluded superficial femoral artery
suprageniculate femoropopliteal bypass Above knee bypass
Groin and suprageniculate incision, venous (Saphenous vein) or PTFE graft with end to side anastomoses. If the saphenous vein is truly applicable for grafting will ultimately be an intra-operative decision (despite pre-operative venous mapping)

Primary Outcomes

Measure
(re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass
time frame: 5 year

Secondary Outcomes

Measure
(a)symptomatic (re)stenosis of the superficial femoral artery or bypass for which a re-intervention was carried out
time frame: 5 year
major amputation of the ipsilateral leg
time frame: 5 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients presenting with Fontaine IIB, III, IV ischemia - Long (>10 cm) occlusion of the superficial femoral artery, with patent popliteal artery and at least 1 patent crural vessel - Atherosclerotic disease Exclusion Criteria: - Previous operations on the superficial femoral artery - Radiation therapy groin/leg region - Diameter superficial femoral artery < 4 mm - Contrast allergy

Additional Information

Official title The Surgical Treatment of Long Occlusions of the Superficial Femoral Artery: Initial Success and Long Term Results of Remote Endarterectomy Versus Suprageniculate Bypass Surgery
Principal investigator Suzanne S Gisbertz, MD
Description Different strategies exist in the treatment of chronic long occlusions of the superficial femoral artery and yet we still suffer a significant percentage of restenosis, re-occlusions and even major amputations, reason for continuous development of new techniques. One such technique is the recently developed minimal invasive remote endarterectomy, which shows promising patency rates and possibly less complications with earlier recovery. A more experienced and the most implemented technique is the suprageniculate femoropopliteal bypass graft, which, when using the saphenous vein, has proved durable. A randomized trial comparing both modalities was lacking so far, what makes the objective of this study a comparison of patency rates between those 2 techniques in a randomized fashion.
Trial information was received from ClinicalTrials.gov and was last updated in November 2007.
Information provided to ClinicalTrials.gov by St. Antonius Hospital.